Drug Interactions between betrixaban and sugammadex

MONITOR: Sugammadex may potentiate the effects of anticoagulants. The mechanism of interaction has not been described. In healthy volunteers, sugammadex doses up to 16 mg/kg were associated with increases in activated partial thromboplastin time (aPTT) and prothrombin time (PT)/international normalized ratio (INR) of up to 25% for up to one hour. In a clinical trial of patients undergoing major orthopedic surgery of the lower extremity who received heparin or low molecular weight heparin (LMWH) for thromboprophylaxis, increases in aPTT and PT/INR of 5.5% and 3.0%, respectively, were observed in the hour following administration of a 4 mg/kg sugammadex dose. The changes in coagulation parameters were not associated with an increased incidence of blood loss or anemia; however, a higher dosage of sugammadex may produce clinically significant effects. In vitro, additional aPTT and PT/INR prolongations of up to approximately 25% and 50% were demonstrated when sugammadex was combined with vitamin K antagonists, unfractionated heparin, low molecular weight heparinoids, rivaroxaban, and dabigatran at peak levels of sugammadex corresponding to 4 mg/kg and 16 mg/kg doses, respectively.

MANAGEMENT: Hemostasis and coagulation parameters should be closely monitored when sugammadex is administered to patients receiving therapeutic anticoagulation for a preexisting or comorbid condition; patients who have received thromboprophylaxis drugs other than heparin and LMWH; or patients who have received thromboprophylaxis with heparin or LMWH and subsequently administered 16 mg/kg of sugammadex.